Senior Director, Analytical Chemistry

Role: Senior Director of Pharmaceutical Development & Operations, leading analytical development and characterization for Celcuity's small molecule pipeline from early to commercial stages. Responsibilities: establish phase-appropriate analytical strategies for drug substance and product, oversee external CDMO testing, troubleshoot analytical issues, support formulation and preclinical characterization, and author/regulatory submit analytical sections for IND/NDA filings. Requirements: PhD, Master's, or Bachelor's in physical sciences (preferably analytical chemistry); ≥12 years in small molecule analytical chemistry, with experience in API, impurity testing, and early IND-enabling development. Preferred: supervision of GLP-compliant LC-MS/MS bioanalytical assays, expertise in technologies including LC, GC, NMR, MS, XRPD, knowledge of FDA, EMA, ICH guidelines. High-Value: small molecule therapeutics, drug substance and product analysis, regulatory submissions, GxP compliance, analytical method validation, cross-functional collaboration. WorkSetup: not specified, likely hybrid or onsite depending on location.